SIST EN ISO 11609:2017
(Main)Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
This document specifies requirements for the physical and chemical properties of dentifrices and
provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling
and packaging of dentifrices.
This document applies to dentifrices, including toothpastes, destined to be used by the consumers on a
daily basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological
hazards are not included in this document. These are covered in ISO 7405[1] and ISO 10993-1[2].
Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prüfverfahren und Kennzeichnung (ISO 11609:2017)
Médecine bucco-dentaire - Dentifrices - Exigences, méthodes d'essai et marquage (ISO 11609:2017)
ISO 11609:2017 spécifie des exigences relatives aux propriétés physiques et chimiques des dentifrices et donne des lignes directrices concernant les méthodes d'essai appropriées. Elle spécifie également des exigences relatives au marquage, à l'étiquetage et à l'emballage des dentifrices.
ISO 11609:2017 s'applique aux dentifrices, y compris les pâtes dentifrices, destinés à être utilisés quotidiennement par les consommateurs avec une brosse à dents, dans le but de favoriser l'hygiène buccale.
ISO 11609:2017 ne spécifie pas d'exigences qualitatives ou quantitatives spécifiques pour une absence de risques biologiques et toxicologiques. Celles-ci sont traitées dans l'ISO 7405[1] et l'ISO 10993‑1[2].
Zobozdravstvo - Zobne paste - Zahteve, preskusne metode in označevanje (ISO 11609:2017)
Ta dokument določa zahteve za fizične in kemijske lastnosti zobnih past in podaja smernice za ustrezne preskusne metode. Določa tudi zahteve za označevanje, etiketiranje in pakiranje zobnih past.
Ta dokument se uporablja za zobne paste, vključno s tistimi, ki so namenjene za vsakdanjo uporabo z zobno ščetko za namene vzdrževanja ustne higiene.
Ta dokument ne zajema posebnih kvalitativnih in kvantitativnih
zahtev glede neprisotnosti bioloških ali toksikoloških tveganj. Te so zajete v standardih ISO 7405[1] in ISO 10993-1[2].
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11609:2017
01-september-2017
1DGRPHãþD
SIST EN ISO 11609:2010
=RER]GUDYVWYR=REQHSDVWH=DKWHYHSUHVNXVQHPHWRGHLQR]QDþHYDQMH ,62
Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prüfverfahren und
Kennzeichnung (ISO 11609:2017)
Médecine bucco-dentaire - Dentifrices - Exigences, méthodes d'essai et marquage (ISO
11609:2017)
Ta slovenski standard je istoveten z: EN ISO 11609:2017
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 11609:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11609:2017
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SIST EN ISO 11609:2017
EN ISO 11609
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 11609:2010
English Version
Dentistry - Dentifrices - Requirements, test methods and
marking (ISO 11609:2017)
Médecine bucco-dentaire - Dentifrices - Exigences, Zahnheilkunde - Zahnreinigungsmittel -
méthodes d'essai et marquage (ISO 11609:2017) Anforderungen, Prüfverfahren und Kennzeichnung
(ISO 11609:2017)
This European Standard was approved by CEN on 12 June 2017.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11609:2017 E
worldwide for CEN national Members.
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SIST EN ISO 11609:2017
EN ISO 11609:2017 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 11609:2017
EN ISO 11609:2017 (E)
European foreword
This document (EN ISO 11609:2017) has been prepared by Technical Committee ISO/TC 106
“Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2017 and conflicting national standards
shall be withdrawn at the latest by December 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11609:2010.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11609:2017 has been approved by CEN as EN ISO 11609:2017 without any modification.
3
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SIST EN ISO 11609:2017
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SIST EN ISO 11609:2017
INTERNATIONAL ISO
STANDARD 11609
Third edition
2017-06
Dentistry — Dentifrices —
Requirements, test methods and
marking
Médecine bucco-dentaire — Dentifrices — Exigences, méthodes
d’essai et marquage
Reference number
ISO 11609:2017(E)
©
ISO 2017
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements relative to the physical and chemical properties of dentifrices .2
4.1 Total fluoride . 2
4.1.1 Total fluoride concentration . 2
4.1.2 Total fluoride in a single-unit container . 2
4.2 Heavy metals . 2
4.3 pH . 2
4.4 Microbiology . 2
4.5 Abrasivity . 2
4.6 Stability . 3
4.7 Readily fermentable carbohydrates . 3
5 Test methods . 3
5.1 Determination of pH . 3
5.2 Determination of dentine abrasivity . 3
5.3 Determination of enamel abrasivity . 3
5.4 Determination of stability . 3
6 Marking and labelling . 3
7 Packaging . 4
Annex A (informative) Abrasivity test procedure — American Dental Association (ADA) method .5
Annex B (informative) Determination of relative dentifrice abrasivity to enamel and
dentine by a surface profile method .12
Annex C (informative) A testing of total fluoride in dentifrices .18
Bibliography .21
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral
care products.
This third edition cancels and replaces the second edition (ISO 11609:2010), which has been technically
revised.
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
Introduction
Dentifrices should not cause any adverse reactions to the oral soft tissues when used in accordance
with the manufacturer’s recommendation for frequency and duration of use, nor cause any known side
effects.
Guidelines on assessing the claimed or implied efficacy of dentifrices for the prevention or control of
[3]
oral conditions can be found through the US Food and Drug Administration , the American Dental
[4] [16]
Association and the Commission Work Project (8-95) of the FDI World Dental Federation .
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SIST EN ISO 11609:2017
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SIST EN ISO 11609:2017
INTERNATIONAL STANDARD ISO 11609:2017(E)
Dentistry — Dentifrices — Requirements, test methods
and marking
1 Scope
This document specifies requirements for the physical and chemical properties of dentifrices and
provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling
and packaging of dentifrices.
This document applies to dentifrices, including toothpastes, destined to be used by the consumers on a
daily basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological
[1] [2]
hazards are not included in this document. These are covered in ISO 7405 and ISO 10993-1 .
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
International Nomenclature of Cosmetic Ingredients (INCI), in International Cosmetic Ingredient
1)
Dictionary and Handbook
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http:// www .electropedia .org/
— ISO Online browsing platform: available at http:// www .iso .org/ obp
3.1
dentifrice
any substance or combination of substances specially prepared for the consumers for hygiene of the
accessible surfaces of teeth and surrounding tissues
3.2
toothpaste
any semi-solid dentifrice preparation presented in the form of a paste, cream or gel
Note 1 to entry: The product’s common constituents are abrasives, humectants, binders, surfactants, flavourings,
fluorides and other agents for oral health benefits.
1) Nomenclature developed by the Personal Care Products Council (formerly CTFA). Available at:
https : // acces s .per s onalcarecouncil .org/ eweb/ DynamicPage .aspx ?Site = pcpc & #x0026;WebKey = 4513b14e -2f75
-4857 -85b4 -b3697be5d5d9.
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
3.3
single-unit container
container of dentifrice marketed to individual consumers
3.4
primary container
container that is in direct contact with the product
4 Requirements relative to the physical and chemical properties of dentifrices
4.1 Total fluoride
4.1.1 Total fluoride concentration
The total fluoride concentration shall not exceed a mass fraction of 0,15 % when tested in accordance
with one of the procedures given in Annex C.
Other validated methods of similar sensitivity and accuracy may be used (see References [5] to [12],
[28] and [29]).
4.1.2 Total fluoride in a single-unit container
The amount of total fluoride in a single-unit container shall not exceed 300 mg.
This requirement does not apply to containers of dentifrice to be dispensed under professionally
supervised conditions or in community-based caries prevention programmes such as school
toothbrushing programmes.
4.2 Heavy metals
The total maximum concentration of heavy metals shall not exceed 20 mg/kg.
Test in accordance with References [13], [14] or [15], or another validated method of similar sensitivity
and accuracy.
4.3 pH
When tested in accordance with 5.1, the dentifrice shall have a pH below 10,5.
4.4 Microbiology
Testing for microbiological contamination shall be carried out according to References [17] to [22] and
[31] to [38] or any other validated method of equivalent sensitivity, accuracy and specificity.
4.5 Abrasivity
The abrasivity of the dentifrice shall not exceed the following limit for dentine:
— 2,5 times that of the primary reference material, if using the procedure specified in Annex A or B;
The abrasivity of the dentifrice shall not exceed the following limit for enamel:
— four times that of the primary reference material, if using the procedure specified in Annex A or B.
Test in accordance with 5.2 or 5.3 or any other validated method of similar sensitivity and accuracy.
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
4.6 Stability
The dentifrice shall show no deterioration that may affect compliance with this document or could
result in toxicological hazards after being subjected to one of the ageing procedures specified in 5.4
or after 30 months of storage at room temperature. If deterioration is detected, the dentifrice shall be
labelled with an expiry date.
4.7 Readily fermentable carbohydrates
The dentifrice shall not contain readily fermentable carbohydrates. Compliance shall be established
by the absence of such compounds in the complete formula or by performing tests in accordance with
commonly used analytical methods.
5 Test methods
5.1 Determination of pH
Suspend one part by mass of the dentifrice into three parts by mass of water for analytical laboratory
use complying with ISO 3696 (grade 3). Determine the pH of the suspension within 10 min, using a pH-
meter and electrode assembly.
5.2 Determination of dentine abrasivity
Determine the mean relative abrasivity compared to the primary reference sample, or any other
reference material calibrated to the primary reference sample for human dentine, using one of the
methods specified in Annex A or B.
Other validated measurement methods on dentine of similar sensitivity and accuracy may be used,
conforming to practices and principles found in References [39] to [44]. For other references see, for
example, References [23] and [24].
5.3 Determination of enamel abrasivity
Determine the mean relative abrasivity compared to the primary reference sample, or any other
reference material calibrated to the primary reference sample for human enamel, using one of the
methods specified in Annex A or B.
Other validated measurement methods on enamel of similar sensitivity and accuracy may be used,
conforming to practices and principles found in References [39] to [44]. For other references see, for
example, References [23] and [24].
5.4 Determination of stability
For the accelerated ageing procedure, the dentifrice shall be stored in its original container at
40 °C ± 2 °C at 75 % ± 5 % relative humidity for 3 months or at such conditions of time and temperature
[25]
as will simulate storage at room temperature for 30 months . Following storage, test the product
according to this document.
6 Marking and labelling
With the exception of small single units (less than 10 ml), all primary containers shall be marked with
the following information:
a) the word “dentifrice” or equivalent (see Clause 3);
b) the trade name;
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
c) the name and contact information of the manufacturer or responsible distributor;
d) the tracking code that includes an intelligible production date;
e) a complete list of ingredients according to the International Nomenclature of Cosmetic
Ingredients (INCI);
f) the concentration and type of fluoride, if present, expressed in micrograms per gram, or percent by
mass, or both;
g) the net volume, in millilitres, or net mass in grams, or both;
h) the expiry date, expressed according to ISO 8601, if the period of stability (shelf-life) is less than
30 months;
i) a safety notice regarding the use, by children below 6 years of age, of dentifrices containing
concentrations of fluoride of 1 000 µg/g or more.
7 Packaging
The product shall be packaged in such a way that under normal conditions of handling and transport,
the container or dispensing system, or both, shall not contaminate or permit contamination of the
dentifrice inside, so as to affect its compliance with this document, after being subjected to the ageing
procedure described in 5.4.
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
Annex A
(informative)
Abrasivity test procedure — American Dental Association (ADA)
method
A.1 General
This annex identifies the specific procedures for determination of the dentifrice abrasivity using the
[26]
ADA laboratory method .
A.2 Sampling
A representative sample shall be taken from at least two batches.
A.3 Procedure
A.3.1 Standard reference abrasive
2)
The primary reference abrasive is from a specific lot of calcium pyrophosphate . An alternate, silica
3)
[27] [30]
reference abrasive , is also available . For the procedure specified in BS 5136 , a chalk reference
dentifrice is also available.
A.3.2 Apparatus
A.3.2.1 Brushing machine.
4)
A cross-brushing machine is the apparatus of choice . The apparatus should have eight positions for
holding specimens. A toothbrush shall be positioned to pass reciprocally at a small angle (approximately
5°) over the mounted specimens, with a designated tension on the brush, while immersed in a
dentifrice slurry. The distance traversed by the brush should not be longer than the brush head so that
the specimen does not lose contact with the brush. The mechanism for holding the dentifrice slurry
may vary with different machine designs, but should allow for easy removal of the slurry sample. It is
important to have some mechanism for the agitation of the slurry while the brushing is taking place. A
convenient method to accomplish this is to attach rubber mixing vanes just below the brush head. As
the brushing takes place, these vanes will prevent the abrasive from settling to the bottom of the slurry
container.
2) Reference calcium pyrophosphate is available from Odontex Inc. 3030 Campfire Dr., Lawrence, KS 66040, USA,
http:// www .odontexusa .com. This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO of this product.
®
3) Alternative reference silica (Sident ) is available from Evonik, Rodenbacher Chaussee 4, 63457 Hanau
Wolfgang, Germany. This information is given for the convenience of users of this document and does not constitute
an endorsement by ISO of this product.
4) An acceptable product is available from Sabri Dental Enterprises, Inc., 1404 Brooke Dr., Downers Grove, IL
60515, USA, http:// www .sabridentalenterprises .com/ p/ about .html. This information is given for the convenience
of users of this document and does not constitute an endorsement by ISO of this product.
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SIST EN ISO 11609:2017
ISO 11609:2017(E)
A.3.2.2 Radioactivity detector.
The two recommended methods for the determination of the radioactivity of the used dentifrice
slurries are a Geiger-Müller planchet counter and a liquid scintillation detector. The use of the Geiger
counter requires that the samples be dried under defined controlled conditions. The liquid scintillation
method has the advantage of reading directly from the slurry.
Counting should be done for a period, expected to reduce the alpha value for counting error to less than
2 %. Counting should be performed for a minimum of 1 000 counts and for at least 1 min. The number of
brushing strokes may be increased if counting times become too long.
A.3.3 Preparation of tooth specimens
A.3.3.1 Dentine specimens
A.3.3.1.1 Selection
Human root dentine of extracted permanent teeth is used as the substrate. Single-rooted teeth that
were vital at extraction should be selected. An exception, because of the small size, are mandibular
incisors: these should not be used. The specimen should be at least 14 mm long and 2 mm wide at the
narrow end. All roots shall be caries-free and free of anatomical defects. After extraction, the roots
should be stored in a neutralized solution that disinfects but does not alter the physical properties.
A.3.3.1.2 Preparation
Scrape the roots clean of all soft tissue and as much cementum as possible. Then remove the crown and
the root tips using a separating disc under a flow of water.
A.3.3.1.3 Irradiation
For each set of eight specimens to be irradiated, add one or two extra roots for use in correction factors.
Pack the specimens in disinfection solution and submit to a nuclear reactor for irradiation. The neutron
32
flux should be sufficient to produce about 1 mCi of P beta radiation after several hours. Elevated
temperatures in the reactor (above 65 °C) should be avoided. A specific position shall be requested
to shield the samples from fast neutrons and gamma radiation. Handling of the irradiated specimens
should be done with care using good laboratory practice. The specimens should not be used during the
first half-life because of excess radiation and should be used before the end of the third half-life because
32
of lack of activity. The half-life of P is 14,3 days so the usable life span of a set of teeth is 4 weeks.
A.3.3.1.4 Mounting of specimens
Mount the specimens individually in a mould in cold-cure methyl methacrylate resin such that either
the buccal or lingual surface protrudes at least 2 mm above and parallel to the resin. Orient the mould
in the brushing machine such that the direction of brushing is perpendicular to the long dimension of
the root. Store the mounted specimens in a neutralized solution that disinfects but does not alter the
physical properties.
NOTE The type and configuration of the mould depend on the holder of the brushing machine.
A.3.3.2 Enamel specimens
A.3.3.2.1 Selection
Selection criteria for enamel specimens are the same as for dentine. The enamel specimens should be
obtained from human maxillary incisors.
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A.3.3.2.2 Preparation
The entire labial surface of the specimen is used after removing the root. Clean the enamel in the same
way as the root.
A.3.3.2.3 Irradiation
Irradiation of the enamel is identical to the method used with the roots. The roots and enamel specimens
may be packed together for submission to the reactor.
A.3.3.2.4 Mounting
Mount the enamel specimens in the same way as the roots. The labial surface shall protrude 2 mm and
be parallel to the resin surface.
A.3.4 Toothbrushes
5)
The toothbrushes used should have nylon filaments about 10 mm in length. Filament ends should lie
in a plane.
Store the brushes in water overnight prior to their first use and then keep them in water until they are
discarded. Use a new set of brushes for each set of teeth. Do not remove the brushes from the machine
between runs but raise the tufts off the specimen so as not to bend the bristles. At the beginning of each
6)
run, set the tension of the brush on the specimen to 150 g using a Chatillon spring gauge or equivalent.
This tension should be rechecked at least twice daily. The method of adjusting the tension will vary
depending upon the type of mechanism on the brushing machine.
A.3.5 Reference diluent
7)
The diluent is a 0,5 % carboxymethyl cellulose (7MF CMC) solution in 10 % glycerine. To prepare 1 l
of the diluent, heat 50 ml of glycerine to 60 °C and add 5 g of CMC while stirring. When the mixture
is homogeneous, add another 50 ml of heated gly
...
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